Hydrocephalus
Conditions
Keywords
Hydrocephalus, Ventriculoperitoneal Shunt, Distal shunt failure, Trocar, Complications
Brief summary
This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable trocar for ventriculoperitoneal shunt.
Detailed description
This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. Patients hospitalized with hydrocephalus will be enrolled and randomly allocated into open mini-laparotomy group (OLG) or abdominal puncture group (APG) for insertion of the peritoneal catheter. Observe will followed for up to at least 6 months after surgery. The primary endpoint is the rate of overall shunt complication or failure within the first 6 months after surgery, and duration of the abdominal catheterization. The secondary endpoints are rate of distal shunt failure, the overall incidence of various adverse reactions, abdominal incision size, analgesic use as evaluated on Day 5 postoperatively, duration of hospital stay. Moreover, neurological function of patients (mRS, maxillary hydrocephalus scale) and CT measurement of Even index will also be evaluated.
Interventions
PROCEDUREOpen Mini-Laparotomy
A 5-cm paraumbilical skin is made, and the abdominal wall is incised in layers. The distal catheter tip is inserted into the peritoneal cavity in a craniocaudal direction, and the abdominal wound is sutured in layers.
PROCEDUREAbdominal Puncture
An about 0.5-cm paraumbilical incision made to allow introduction of a splitable trocar. The trocar is pierced through the abdominal wall into the abdominal cavity. Pull out the puncture cone, and adjust the trocar towards the pelvis. The distal catheter tip is inserted into the peritoneal cavity through the puncture cannula. Then the splitable puncture cannula is split apart and removed. The skin incision requires only one stitch.
Sponsors
Southern Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years or older with new-onset hydrocephalus, including obstructive hydrocephalus, traffic hydrocephalus and special types of hydrocephalus, normal pressure hydrocephalus (NPH), idiopathic intracranial hypertension (IIH), benign intracranial hypertension, pseudotumor cerebri, etc., regardless of gender. 2. Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt. 3. Provided written informed consent.
Exclusion criteria
1. Previous abdominal surgery (except ventriculoperitoneal shunt). 2. Pregnancy 3. Peritonitis 4. Patients with cognitive impairment and inability to communicate. 5. Expected survival less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of shunt failure | 6 months | Overall rate of shunt failure requiring revision |
| Duration of the abdominal catheterization | During the surgery | Duration of the abdominal catheterization, defined as the time from abdominal incision to abdominal skin suture completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal incision size | During the surgery | Abdominal incision size |
| The incidence of adverse reactions | 6 months | The overall incidence of various adverse reactions |
| Duration of hospita stay | During perioperative period | Duration of hospita stay, defined as day of admission until discharge from the neurosurgical ward. |
| The incidence of anargesic drug use | Day 5 after surgery | The incidence of anargesic drug use as evaluated on day 5 postoperatively |
| Rate of distal shunt failure | 6 months | Rate of distal shunt failure requiring revision |
Countries
China
Contacts
Primary ContactZhen-Zhou Chen, Dr.
Outcome results
None listed